RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, …



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA

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SYNOPSIS

OF

DISSERTATION

"A PROSPECTIVE STUDY OF ULTRASOUND MEASUREMENT OF CERVICAL LENGTH IN PREGNANT WOMEN BETWEEN 18 TO 24 WEEKS OF GESTATION FOR PREGNANCY OUTCOME IN RURAL SCENARIO"

Submitted by

Dr. VINAYACHANDRA SINGH. P

M.B.B.S.

POST GRADUATE STUDENT IN

OBSTETRICS AND GYNAECOLOGY (M.S)

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DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY

ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES,

B.G.NAGARA-571448

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

| | | |

|1 |NAME OF THE CANDIDATE |Dr. VINAYACHANDRA SINGH. P |

| |AND ADDRESS |P.G IN OBSTETRICS & GYNAECOLOGY, |

| |(in block letters) |ADICHUNCHUNAGIRI INSTITUTE OF |

| | |MEDICAL SCIENCES.B.G NAGARA, |

| | |MANDYA DISTRICT -571448 |

|2. |NAME OF THE INSTITUTION |ADICHUNCHANAGIRI INSTITUTE OF |

| | |MEDICAL SCIENCES, B.G.NAGARA. |

|3. |COURSE OF STUDY AND SUBJECT |M.S. IN OBSTETRICS & GYNAECOLOGY |

|4. |DATE OF ADMISSION TO COURSE |25TH APRIL 2011 |

| | |"A PROSPECTIVE STUDY OF ULTRASOUND MEASUREMENT OF CERVICAL LENGTH IN |

|5. |TITLE OF THE TOPIC |PREGNANT WOMEN BETWEEN 18 TO 24 WEEKS OF GESTATION FOR PREGNANCY |

| | |OUTCOME IN RURAL SCENARIO" |

|6. |BRIEF RESUME OF INTENDED WORK |APPENDIX-I |

| |NEED FOR THE STUDY |APPENDIX-IA |

| |6.2 REVIEW OF LITERATURE |APPENDIX-IB |

| |6.3 OBJECTIVES OF THE STUDY |APPENDIX-IC |

|7 |MATERIALS AND METHODS |APPENDIX-II |

| | | |

| |SOURCE OF DATA |APPENDIX-IIA |

| | | |

| |7.2 METHOD OF COLLECTION OF DATA : (INCLUDING SAMPLING PROCEDURE | |

| |IF ANY) |APPENDIX-IIB |

| | | |

| |7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS TO | |

| |BE CONDUCTED ON PATIENTS OR OTHER ANIMALS, IF SO PLEASE DESCRIBE | |

| |BRIEFLY. |YES |

| | |APPENDIX-IIC |

| |7.4 HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION IN | |

| |CASE OF 7.3 | |

| | | |

| | |YES |

| | |APPENDIX-IID |

|8. |LIST OF REFERENCES | APPENDIX - III |

| | | |

|9. |SIGNATURE OF THE CANDIDATE | |

| | |Assessment of cervical length by obstetric imaging is one of the must|

|10. |REMARKS OF THE GUIDE |do documentation. Cervical length of < 2.5 cm is considered risk |

| | |factor for preterm delivery in many research papers. This study is |

| | |undertaken to assess this at our institution. |

|11 |NAME AND DESIGNATION | |

| |(in Block Letters) | |

| | | |

| |11.1 GUIDE |Dr. RAMESH BABU, M.D |

| | |ASSOCIATE PROFESSOR |

| | |DEPARTMENT OF OBSTETRICS AND GYNECOLOGY |

| | |AIMS, B.G. NAGARA-571448 |

| | | |

| |11.2 SIGNATURE OF THE GUIDE | |

| | | |

| |11.3 CO-GUIDE (IF ANY) |- |

| |11.4 SIGNATURE |- |

| | | |

| |11.5 HEAD OF DEPARTMENT |Dr. S. VIJAYALAKSHMI, M.D, D.G.O |

| | |PROFESSOR AND HEAD |

| | |DEPARTMENT OF OBSTETRICS AND GYNECOLOGY |

| | |AIMS, B.G. NAGARA-571448 |

| | | |

| |11.6 SIGNATURE | |

| | | |

| | | |

|12 |12.1 REMARKS OF THE CHAIRMAN |The facilities required for the investigation will be made available |

| |AND PRINCIPAL |by the college |

| | | |

| | |Dr. M.G. SHIVARAMU, M.B.B.S, M.D. |

| | |PRINCIPAL, |

| | |AIMS, B.G. NAGARA. |

| | | |

| |12.2 SIGNATURE | |

| | | |

APPENDIX-I

6.BRIEF RESUME OF THE INTENDED WORK:

APPENDIX –I A

6.1 NEED FOR THE STUDY:

Preterm delivery continues to be a significant obstetric problem in view of prematurity complications that an immature new born develops. Cervical length is considered to be one of the important predictors of the risk of preterm delivery. In the era of ultrasound imaging transvaginal ultrasound assessment of cervical length is more accurate than traditional digital assessment.

In this background the present study is undertaken to assess the bearing of cervical length at 18-24 weeks gestation on the time of delivery.

APPENDIX –I B

6.2 REVIEW OF LITERATURE

Ultrasound assessment of the cervix, in recent decades, has become an important part of obstetric diagnostic imaging, especially since the development of transvaginal probes and the increasing acceptance by patients of transvaginal sonography during pregnancy20.

Prediction of the high-risk group for preterm delivery, especially at ≤ 32 weeks, and useful intervention to prevent this complication of pregnancy constitute major challenges in obstetrics4.

Labor that begins between 20 and 37 weeks gestation is appropriately termed preterm. Some of the precipitating factors of preterm labor are changes in cervical status including dilatation and effacement. Until recently, a digital pelvic examination was considered the gold standard for evaluating cervical changes. Current research promotes the use of sonography for the prediction of preterm labor. It is essential for sonographers to become familiar with the various methods of cervical imaging including transabdominal, translabial, and transvaginal approaches19.

Preterm birth is the ultimate result of several different pathways that culminate in the initiation of labor before 37 weeks’ gestation. It is useful to place preterm births in two broad categories—those that are obstetrically indicated (i.e., when preterm delivery serves to benefit the mother or fetus) and those that are spontaneous (i.e., when preterm delivery occurs in the apparent absence of maternal or fetal jeopardy)12.

Recently, several studies in pregnancies considered at high risk, because of a history of previous mid-trimester miscarriage or early preterm delivery, and those presenting with preterm labor, have reported that cervical assessment may provide useful prediction of preterm delivery4.

Early detection of pregnant women who will deliver before term has been sought as an avenue to reduce the occurrence of prematurity-related perinatal morbidity and mortality. Preterm birth is associated with 75% of perinatal morbidity and mortality for infants born without congenital anomalies. Sequelae of preterm birth include cerebral palsy, developmental delay, visual and hearing impairment, and chronic lung disease. The rates of preterm and low birth weight deliveries have actually increased in recent years despite widespread efforts to address the problem12.

Vaginal-probe sonographic cervical assessment has been evaluated extensively over the past decade. Technique is important, and Yost and colleagues (1999) have cautioned that special expertise is needed. Iams and co-workers (1996) measured cervical length at approximately 24 weeks and again at 28 weeks in 2915 women not at risk for preterm birth. The mean cervical length at 24 weeks was approximately 35 mm, and those women with progressively shorter cervices experienced increased rates of preterm birth16.

Cervical length is normally distributed and remains relatively constant until the third trimester. Heath found at 23 weeks a mean length of 38 mm. Iams found a mean length at 24 weeks of 35 mm and at 28 weeks of 34 mm. If funnelling is present, measurement should exclude the funnel and be taken from the funnel tip to the external os18.

Preterm birth is the leading cause of perinatal mortality and morbidity. Despite advances in perinatal care, the incidence of preterm birth continues to rise primarily due to increased multiple pregnancies as a result of assisted reproduction. Tocolytics prolong pregnancy minimally once preterm labour has begun and are associated with significant undesirable maternal, fetal, and neonatal consequences. To address the prematurity problem, identification of those at increased risk is an important objective18.

Increased preterm birth risk is associated with many variables, including socioeconomic marginalization, previous preterm birth, cervical ‘incompetence,’ smoking, and nonmedical drug use. Pregnancy complications that increase likelihood of preterm birth include multiple gestation, polyhydramnios, vaginal bleeding, certain uterine anomalies, and excessive uterine contractions. Despite these important associations, maternal risk scoring fails to detect up to 70 percent of infants who are delivered spontaneously before term18.

Recent studies of the epidemiology and pathophysiology of preterm birth have identified four pathways leading to preterm labor and delivery:

1) Inflammation

2) Decidual hemorrhage

3) Uterine over-distention

4) Premature activation of the normal physiologic initiators of labor12.

Inflammation is more often associated with preterm births before 32 weeks, whereas decidual hemorrhage may occur at any time. Uterine over-distention may accompany multifetal gestation, polyhydramnios, or a uterine anomaly. Premature activation of the normal maternal-fetal hypothalamic-pituitary-adrenal axis is typical of preterm labor after 32–34 weeks. Much of the data that underlie these observations have come from studies of markers for preterm delivery such as cervical ultrasound images, fetal fibronectin, the thrombin cascade, and maternal salivary estriol measured in asymptomatic women with and without risk factors for preterm birth12.

Early detection of preterm labor is difficult because initial symptoms and signs are often mild and may occur in normal pregnancies. Thus, many healthy women will report symptoms during routine prenatal visits, whereas others destined for preterm birth may dismiss the early warning signs as normal in pregnancy. The traditional criteria for preterm labor (persistent contractions accompanied by progressive cervical dilatation and effacement) are most accurate when contraction frequency is six or more per hour, cervical dilatation is 3 cm or more, effacement is 80% or more, membranes rupture, or bleeding occurs12.

Ultrasound images of the cervix in pregnancy have shown that cervical effacement begins weeks before delivery, at about 32 weeks for term births and as early as 16–24 weeks for preterm births. Effacement begins at the internal cervical os and proceeds caudal through a process called funneling. This process is often well established before the external os dilates. Zilianti et al described the appearance of cervical effacement as seen by transvaginal sonography as a progression of the letters T, Y, V, and U to denote the relationship of the cervical canal to the lower uterine segment. Their concept is depicted in modified form in the following Figure12.

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Studies of transvaginal cervical sonography have reported different thresholds depending on the patients studied (symptoms versus no symptoms) and the goal of the analysis (accurate detection of preterm labor in women with symptoms versus prediction of preterm birth in asymptomatic outpatients). In symptomatic women, the optimal threshold to exclude a diagnosis of preterm labor is 30 mm. A cervical length of 18 –20 mm has optimal positive predictive value in this setting12.

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APPENDIX –IC

6.3 AIMS AND OBJECTIVES OF STUDY

• To assess the relation of cervical length at mid-trimester in singleton uncomplicated pregnancies on the time of delivery.

• To examine the potential value of routine measurement of cervical length in singleton pregnancies between 18-24 weeks of gestation in the prediction of the risk for early spontaneous preterm delivery.

APPENDIX-II

7.0 MATERIALS AND METHODS

APPENDIX-II A

7.1 SOURCE OF DATA

Study Design : A prospective study

Study Period : 24 Months (November 2011 to October 2013)

All booked cases coming to Adichunchanagiri Institute of Medical Sciences willing to participate in the study are to be included. Pregnant women having gestation age between 18-24 weeks with singleton pregnancies are included. Patients cervical length is measured by ultrasonography and they are followed up for the pregnancy outcome.

APPENDIX-II B

1. METHOD OF COLLECTION OF DATA

Sample Size : A prospective study of a sample size of minimum of 250 cases fulfilling the mentioned inclusion criteria will be part of the study.

INCLUSION CRITERIA

• All singleton pregnancies who have the correct dating (reliable LMP in the background of regular menstrual cycles or ultrasound dating done in the first trimester), who came for anomaly scan between 18-24 weeks are included for cervical length measurement with transvaginal ultrasound scanning.

EXCLUSION CRITERIA

• Those who are not willing to give their consent for the involvement in the study or those not giving consent for transvaginal ultrasound measurement of cervical length.

• Those who developed medical or surgical complications in the later period and got terminated iatrogenically.

• Those who missed follow up.

APPENDIX-II C

7.3 Does the study require any investigation or intervention to be conducted on the patients or animals, if so please describe briefly

YES

Investigation :

• Haemoglobin estimation

• Complete blood count

• Blood group and Rh type

• HIV / HBsAg & VDRL

• Urine sugar, albumin and microscopy

• GCT

• Thyroid profile

• Ultrasonography

APPENDIX-IID

PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL

| |SECTION A | |

|a |Title of the study |"A PROSPECTIVE STUDY OF ULTRASOUND MEASUREMENT OF CERVICAL LENGTH IN |

| | |PREGNANT WOMEN BETWEEN 18 TO 24 WEEKS OF GESTATION FOR PREGNANCY OUTCOME IN|

| | |RURAL SCENARIO" |

|b |Principle investigator |Dr. VINAYACHANDRA SINGH. P |

| |(Name and Designation) |P.G IN OBSTETRICS AND GYNAECOLOGY, |

| | |ADICHUNCHUNAGIRI INSTITUTE OF |

| | |MEDICAL SCIENCES.B.G NAGARA, |

| | |MANDYA DISTRICT -571448 |

|c |Co-investigator | |

| |(Name and Designation) |Dr. RAMESH BABU, M.D |

| | |ASSOCIATE PROFESSOR |

| | |DEPARTMENT OF OBSTETRICS AND GYNECOLOGY |

| | |AIMS, B.G. NAGARA-571448 |

|d |Name of the Collaborating |NA |

| |Department/Institutions | |

|e |Whether permission has been obtained from the heads of the |NA |

| |collaborating departments & Institution | |

| |Section – B |APPENDIX - I |

| |Summary of the Project | |

| |Section – C |APPENDIX - IC |

| |Objectives of the study | |

| |Section – D |APPENDIX - IIB |

| |Methodology | |

|A |Where the proposed study will be undertaken |DEPARTMENT OF O.B.G., |

| | |S.A.H. & R.C., B.G.NAGARA |

|B |Duration of the Project |24 MONTHS |

|C |Nature of the subjects: | |

| |Does the study involve adult patients? |YES |

| |Does the study involve Children? |NO |

| |Does the study involve normal volunteers? |NO |

| |Does the study involve Psychiatric patients? |NO |

| |Does the study involve pregnant women? |YES |

|D |If the study involves health volunteers | |

| |Will they be institute students? |NO |

| |Will they be institute employees? |NO |

| |Will they be Paid? |NO |

| |If they are to be paid, how much per session? |NO |

|E |Is the study a part of multi central trial? |NO |

|F |If yes, who is the coordinator? | |

| |(Name and Designation) |NA |

| | | |

| |Has the trail been approved by the ethics Committee of the other |NA |

| |centers? | |

| | | |

| |If the study involves the use of drugs please indicate whether. |NO |

| | | |

| |I. The drug is marketed in India for the indication in which it will | |

| |be used in the study. |NO |

| | | |

| |II. The drug is marketed in India but not for the indication in | |

| |which it will be used in the study | |

| | |NO |

| |III. The drug is only used for experimental use in humans. | |

| | | |

| |IV. Clearance of the drugs controller of India has been obtained for:| |

| | |NO |

| | | |

| |Use of the drug in healthy volunteers | |

| |Use of the drug in-patients for a new indication. |NO |

| |Phase one and two clinical trials | |

| |Experimental use in-patients and healthy volunteers. | |

| | | |

| | |NO |

|G |How do you propose to obtain the drug to be used in the study? |NA |

| |Gift from a drug company | |

| |Hospital supplies | |

| |Patients will be asked to purchase | |

| |Other sources (Explain) | |

|H |Funding (If any) for the project please state |NA |

| |None | |

| |Amount | |

| |Source | |

| |To whom payable | |

|I |Does any agency have a vested interest in the out come of the Project? |NO |

|J |Will data relating to subjects /controls be stored in a computer? |YES |

|K | Will the data analysis be done by | |

| |The researcher? |YES |

| |The funding agent |NO |

|L |Will technical / nursing help be required form the staff of hospital. | |

| | |NO |

| |If yes, will it interfere with their duties? | |

| | |NO |

| |Will you recruit other staff for the duration of the study? | |

| | |NO |

| |If Yes give details of | |

| |Designation | |

| |Qualification | |

| |Number |NA |

| |Duration of Employment | |

|M |Will informed consent be taken? If yes |NA |

| |Will it be written informed consent: | |

| |Will it be oral consent? Will it be| |

| |taken from the subject themselves? | |

| |Will it be from the legal guardian? If no, give reason: | |

|N |Describe design, Methodology and techniques |APPENDIX II |

Ethical clearance has been accorded.

Chairman,

P.G Training Cum-Research Institute,

A.I.M.S., B.G.Nagara.

Date :

PS : NA – Not Applicable

APPENDIX-III

8. LIST OF REFERENCES

1. Iams JD, Goldenberg RL, Meis PJ, et al. The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. N Engl J Med 1996; 334:567.

2. Taipale P, Hiilesmaa V. Sonographic measurement of uterine cervix at 18-22 weeks' gestation and the risk of preterm delivery. Obstet Gynecol 1998; 92:902.

3. Hibbard JU, Tart M, Moawad AH. Cervical length at 16-22 weeks' gestation and risk for preterm delivery. Obstet Gynecol 2000; 96:972.

4. Heath VC, Southall TR, Souka AP, et al. Cervical length at 23 weeks of gestation: prediction of spontaneous preterm delivery. Ultrasound Obstet Gynecol 1998; 12:312.

5. Owen J, Yost N, Berghella V, et al. Can shortened midtrimester cervical length predict very early spontaneous preterm birth? Am J Obstet Gynecol 2004; 191:298.

6. Owen J, Yost N, Berghella V, et al. Mid-trimester endovaginal sonography in women at high risk for spontaneous preterm birth. JAMA 2001; 286:1340.

7. Iams JD, Johnson FF, Sonek J, et al. Cervical competence as a continuum: a study of ultrasonographic cervical length and obstetric performance. Am J Obstet Gynecol 1995; 172:1097.

8. Crane JM, Hutchens D. Transvaginal sonographic measurement of cervical length to predict preterm birth in asymptomatic women at increased risk: a systematic review. Ultrasound Obstet Gynecol 2008; 31:579.

9. Berghella V, Baxter JK, Hendrix NW. Cervical assessment by ultrasound for preventing preterm delivery. Cochrane Database Syst Rev 2009; :CD007235.

10. American College of Obstericians and Gynecologists. ACOG Practice Bulletin. Cervical insufficiency. Obstet Gynecol 2003; 102:1091.

11. Iams JD. Prediction and early detection of preterm labor. Obstet Gynecol 2003; 101:402.

12. Tsoi E, Akmal S, Rane S, et al. Ultrasound assessment of cervical length in threatened preterm labor. Ultrasound Obstet Gynecol 2003; 21:552.

13. Tsoi E, Fuchs IB, Rane S, et al. Sonographic measurement of cervical length in threatened preterm labor in singleton pregnancies with intact membranes. Ultrasound Obstet Gynecol 2005; 25:353.

14. Sotiriadis A, Papatheodorou S, Kavvadias A, Makrydimas G. Transvaginal cervical length measurement for prediction of preterm birth in women with threatened preterm labor: a meta-analysis. Ultrasound Obstet Gynecol 2010; 35:54.

15. Williams Obstetrics 23rd edition page 814,815

16. Jignesh J Kansaria, Alka Gupta, S V Paulekar. Cervical sonography to to assess risk of preterm labour. Bombay hospital journal 2009;51:174-184.

17. Michiel Van den Hof et al. Ultrasound cervical assessment in predicting preterm birth. SOGC clinical practice guidelines 2001;102:1-4.

18. Shumaila S. Malik, Ayesha Maqbool, Safdar A. Malik. Role of transvaginal ultrasound in cervical length changes during normal pregnancy. Biomedica 2009;25:175-179.

19. M.H.B. Carvalho et al. Cervical length at 11-14 weeks and 22-24 weeks gestation evaluated by transvaginal sonography and gestational age at delivery. Ultrasound Obstet gynecol 2003;21:135-139.

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